Buprenorphine is a medication approved by the Food and Drug Administration (FDA) to treat Opioid Use Disorder (OUD).
What is Buprenorphine?
Buprenorphine is a medication approved by the Food and Drug Administration (FDA) to treat opioid use disorder (OUD) as a medication-assisted treatment (MAT). As with all medications used in MAT, buprenorphine should be prescribed as part of a comprehensive treatment plan that includes counseling and other behavioral therapies to provide patients with a whole-person approach.
Buprenorphine is the first medication to treat OUD that can be prescribed or dispensed in physician offices, significantly increasing access to treatment. The Drug Addiction Treatment Act of 2000 (DATA 2000), the Comprehensive Addiction and Recovery Act (CARA) and the Substance Use-Disorder Prevention Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act allows qualified practitioners to dispense or prescribe buprenorphine for the treatment of opioid use disorders (OUD) in settings other than opioid treatment programs (OTP), upon completion of specialized training.
To receive a waiver to administer, dispense, and prescribe buprenorphine, office-based practitioners must notify SAMHSA’s Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT) of their intent to practice this form of medication-assisted treatment (MAT). The NOI must be submitted to SAMHSA before the initial dispensing or prescribing of OUD treatment medication. Recently published Practice Guidelines have created a training flexibility for the Notifications of Intent (NOI) to prescribe Buprenorphine:
- In order to apply for subsequent increases in the number of clients eligible for treatment with buprenorphine, office-based providers are obliged to undertake required training activities. Completion of required training accompanies the NOI. This pathway recognizes the importance of specialized training in managing a larger panel of patients who might require treatment with buprenorphine.
- To expand access to buprenorphine, the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, exempts eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives from the certification requirements related to training, counseling and other ancillary services (i.e., psychosocial services) under 21 U.S.C. § 823(g)(2)(B)(i)-(ii) of the Controlled Substances Act (CSA).
Practitioners utilizing this exemption are limited to treating no more than 30 patients at any one time (time spent practicing under this exemption will not qualify the practitioner for a higher patient limit). This exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine.
An eligible provider may choose to undertake training, or forego it prior to prescribing buprenorphine. As noted above, those who forego training are limited to treating no more than 30 patients at any one time.
Several federal laws and regulations permit physicians and other medical personal to administer medications approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorders (OUD) under special circumstances without a buprenorphine waiver. Learn about these special circumstances.
Buprenorphine offers several benefits to those with OUD and to others for whom treatment in a methadone clinic is not appropriate or is less convenient. The following buprenorphine products are FDA approved for the treatment of OUD:
- Generic Buprenorphine/naloxone sublingual tablets
- Buprenorphine sublingual tablets (Subutex)
- Buprenorphine/naloxone sublingual films (Suboxone)
- Buprenorphine/naloxone) sublingual tablets (Zubsolv)
- Buprenorphine/naloxone buccal film (Bunavail)
- Buprenorphine implants (Probuphine)
- Buprenorphine extended-release injection (Sublocade)
Refer to the individual product websites for a complete listing of drug interactions, warnings, and precautions.
How Buprenorphine Works
Buprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With buprenorphine, however, these effects are weaker than full opioid agonists such as methadone and heroin.
When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that help:
- Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings
- Increase safety in cases of overdose
- Lower the potential for misuse
Buprenorphine for Opioid Use Disorder
- To begin treatment, an OUD patient must abstain from using opioids for at least 12 to 24 hours and be in the early stages of opioid withdrawal. Patents with opioids in their bloodstream or who are not in the early stages of withdrawal, may experience acute withdrawal.
- After a patient has discontinued or greatly reduced their opioid use, no longer has cravings, and is experiencing few, if any, side effects, if needed, the dose of buprenorphine may be adjusted. Due to the long-acting agent of buprenorphine, once patients are stabilized, it may be possible to switch from every day to alternate-day dosing.
- The length of time a patient receives buprenorphine is tailored to meet the needs of each patient, and in some cases, treatment can be indefinite. To prevent possible relapse, individuals can engage in on-going treatment—with or without MAT.
Before Starting Buprenorphine
Patients diagnosed with an OUD should talk to their health care practitioner before starting treatment with buprenorphine to fully understand the medication and other available treatment options.
Common and Serious Side Effects of Buprenorphine
Common side effects of buprenorphine include:
- Constipation, headache, nausea, and vomiting
- Drowsiness and fatigue
- Dry mouth
- Tooth decay
- Muscle aches and cramps
- Inability to sleep
- Blurred vision or dilated pupils
- Disturbance in attention
Serious side effects of buprenorphine include:
- Respiratory distress
- Adrenal insufficiency
- Itching, pain, swelling, and nerve damage (implant)
- Pain at injection site (injection)
- Neonatal abstinence syndrome (in newborns)
These are not all the side effects of buprenorphine. For more information patients should talk to their health care practitioner or pharmacist. Patients should tell their health care practitioner about any side effects that are bothersome, or do not go away.
Patients and practitioners are encouraged to report all side effects online to MEDWatch, FDA’s medical product safety reporting program for health care professionals, patients, and consumers or by calling 1-800-FDA-1088.
People should use the following precautions when taking buprenorphine:
- Do not take other medications without first consulting your doctor.
- Do not use illegal drugs, drink alcohol, or take sedatives, tranquilizers, or other drugs that slow breathing. Mixing large amounts of other medications with buprenorphine can lead to overdose or death.
- Ensure that a physician monitors any liver-related health issues that you may have.
- Tell your doctor if you are pregnant or plan to become pregnant.
- Prevent children and pets from accidental Ingestion by storing it out of reach. For more information, visit CDC’s Up and Away educational campaign.
- Dispose of unused methadone safely. Talk to your MAT practitioner for guidance, or for more information on the safe disposal of unused medications, visit FDA's disposal of unused medicines or DEA's drug disposal webpages
- Do not shared your buprenorphine with anyone even if they have similar symptoms or suffer from the same condition.
Buprenorphine Misuse Potential
- Because of buprenorphine’s opioid effects, it can be misused, particularly by people who do not have an opioid dependency. Naloxone is added to buprenorphine to decrease the likelihood of diversion and misuse of the combination drug product.
Learn about other MAT medications.
Treating Pregnant or Breastfeeding Women
Buprenorphine may be prescribed to women who are pregnant and have an OUD. Buprenorphine and methadone are considered the treatments of choice for OUD in pregnant and breastfeeding women.
For more information about the use MAT during pregnancy refer to the Resources and Publications section below.
Switching from one form of MAT Medication to Another
- Patients may decide to switch from one MAT medication to another based on medical, psychiatric and substance use history, as well as their preferences and treatment availability.
- As medications are different, patients should talk to their practitioner and understand each medication.
Learn about other MAT medications.
Training on Providing Buprenorphine
SAMHSA offers tools, training, and technical assistance to practitioners in the fields of mental and substance use disorders. Find information on SAMHSA training and resources. SAMHSA has developed a Buprenorphine Quick Start Guide (PDF | 1.4 MB) and pocket guide (PDF | 200 KB) for all practitioners seeking to prescribe buprenorphine.
Resources and Publications
- A Collaborative Approach to the Treatment of Pregnant Women with Opioid Use Disorders - 2016
- Advisory: Sublingual and Transmucosal Buprenorphine for Opioid Use Disorder: Review and Update - 2016
- Are You Taking Medicine for Opioid Use Disorder and Are Pregnant or Thinking about Having a Baby? - 2019
- Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants - 2018
- The Facts about Buprenorphine for Treatment of Opioid Addiction - 2015 – also available in Cambodian/Khmer, Chinese, Korean, Russian, Spanish, and Vietnamese
- Good Care for You and Your Baby While Receiving Opioid Use Disorder Treatment - 2018
- Healthy Pregnancy Healthy Baby Fact Sheets - 2018
- Opioid Use Disorder and Pregnancy - 2018
- TIP 63: Medications for Opioid Use Disorder – Introduction to Medications for Opioid Use Disorder Treatment (Part 1 of 5) - 2020
- Transitioning from Methadone to Buprenorphine
- Treating Babies Who Were Exposed to Opioids Before Birth - 2018
- Treating Opioid Use Disorder During Pregnancy - 2018